BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST

    K Number: K880157 · Decision Feb 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    448
    Review Days
    22

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    Basic Information

    Device Name
    MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
    K Number
    K880157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Syva Co.
    Date Received
    January 13, 1988
    Decision Date
    February 4, 1988
    Product Code
    GON
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GON Antigen, Cf (Including Cf Control), Rubella

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